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Completed

NCT Number: NCT03933943

A Study of LY3361237 in Participants With Systemic Lupus Erythematosus

The main purpose of this study is to learn more about the safety of LY3361237 and any side effects that might be associated with it when given to participants with systemic lupus erythematosis (SLE). LY3361237 will be administered by injections just under the skin. The study will last up to 26 weeks and may include up to 17 visits to the study center.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pinnacle Research Group, Anniston, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must have received a diagnosis of SLE at least 24 weeks before screening (at least 4 of 11 criteria in 1997 revised American College of Rheumatology [ACR] classification)
  • If a participant is taking oral prednisone (or prednisone equivalent) for SLE, the dose must be ≤20 milligrams per day (mg/day) for at least 8 weeks prior to screening, and must have been stable for at least the last 2 weeks
  • If a participant is taking any of the following medications for SLE, the medication must have been used for at least 12 weeks and stable for at least the last 8 weeks:
  • Azathioprine ≤200 mg/day
  • Antimalarial (e.g., chloroquine, hydroxychloroquine, quinacrine)
  • Mycophenolate mofetil ≤2 g/day or mycophenolic acid ≤1.44 grams per day (g/day)
  • Oral, SC, or intramuscular methotrexate ≤15 milligrams per week (mg/week)

Exclusion criteria

  • Participants must not have a history of, or current, inflammatory joint or skin disease other than SLE
  • Participants must not have a current active bacterial, viral, or fungal infection
  • Participants must not have evidence of significant liver or kidney dysfunction
  • Participants must not have received cytotoxic medications (e.g., cyclophosphamide) within the last 3 months.
  • Participants must not have received any intra-articular, intramuscular, or intravenous glucocorticoids within the last 3 months
  • Participants must not have received blood products (e.g., blood transfusion, platelets, etc.) within the last 12 months

Treatment and study plan

LY3361237

Drug

Administered SC

Placebo

Drug

Administered SC

Primary outcomes

  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug

    Time frame: Baseline through Day 155

    A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3361237

    Time frame: Day 1 predose through Day 155

    PK: Cmax of LY3361237

  2. PK: Area Under the Concentration Versus Time Curve (AUC) Over the Dosing Interval of LY3361237

    Time frame: Day 1 predose through Day 155

    PK: AUC Over the Dosing Interval of LY3361237

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 1, Randomized, Placebo-Controlled, Multiple- Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3361237 in Patients With Systemic Lupus Erythematosus

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 1, 2019
Registry last updated
Mar 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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